Zohydro drugmaker sues Mass. over ban

Tuesday

Apr 8, 2014 at 3:03 AMApr 8, 2014 at 3:14 AM

Zogenix, which makes Zohydro, filed suit in U.S. District Court in Massachusetts on Monday.

Chris Burrell The Patriot Ledger @Burrell_Ledger

State legislators said they were already bracing for the maker of Zohydro, a controversial new prescription painkiller, to fight Massachusetts’ recent ban on allowing doctors to prescribe the drug.Zogenix, which makes Zohydro, filed suit in U.S. District Court in Massachusetts on Monday requesting that the court temporarily stop Gov. Deval Patrick’s executive order, which came two weeks ago as part of his declaration that opiate overdoses are a public health emergency.

A hearing is scheduled for this afternoon, according to court records. Officials from the state Department of Public Health said late Monday that they are reviewing the complaint.

Zohydro is the first commercially available pure form of hydrocodone, the main ingredient in drugs like Vicodin.

It was approved without safeguards to make it tamper-resistant and is up to 10 times more potent than Vicodin.

Concerned that the ban on Zohydro could be lifted, state legislators are expected to jump into the fray too.

“There was some expectation that (Zogenix) might take this action,” state Sen. John Keenan, D-Quincy, said Monday night. “The governor putting the moratorium in place did the right thing.”

Keenan, who pressed federal regulators in 2012 to reject Zohydro’s approval, said he and 56 other state legislators are backing a bill that would restrict how the drug is prescribed.

“We need a responsible protocol for Zohydro,” said Keenan.

The San Diego-based company argues in its lawsuit that Patrick’s order is at odds with the U.S. Food and Drug Administration, which approved use of Zohydro for severe pain in October.

Law enforcement and public health officials fear the powerful painkiller could worsen the nation’s deadly scourge of heroin and prescription drug abuse.

In March, Patrick declared a public health emergency in response to the state’s growing epidemic of heroin and opioid addiction. As part of that announcement, the governor gave the state public health commissioner certain emergency powers, including banning Zohydro “until determined that adequate measures are in place to safeguard against the potential for diversion, overdose, and misuse.”

The ban is an “impermissible” effort by Massachusetts to set its own drug policy, Zogenix says in its suit. “It impedes the FDA’s Congressional mandate to approve a range of safe treatments to promote the public health.”

State Sen. Robert Hedlund, R-Weymouth, is co-sponsoring the legislation to hem in Zohydro prescriptions, but said the state needs to look more closely at the range of painkillers that are being abused.

“A broader looks needs to be undertaken,” said Hedlund. “But the time for this is now. We’re losing a lot of people (to overdoses).”

Material from The Associated Press was used in this report. Chris Burrell may be reached at cburrell@ledger.com or follow him on Twitter @Burrell_Ledger.